|
Post by esstan2001 on Mar 30, 2014 9:59:04 GMT -5
I too agree that a decidedly biased tone comes thru from the reviewer; and also noted the extensive use of 'I' in the statistician's section, leading me to believe this person has an ego. I think there are enough questions on T1 to impact the panel vote but I think T2 should pass if the presentations are good. What concerns me are the dosing discrepancies highlighted by the FDA- 1. Must they be resolved as part of the label (regarding the rough equivalence to IA; I do not see why this would have to be mandated before appvl- I am hoping that it gets considered more as a 'nice to know' to help you understand where you are in terms of Afrezza dosing relative to SC injectables.. ) 2. Are there issues that need to be resolved regarding the inconsistent selection of PK vs PD data during the clamp dosing study? 3. If they need resolution, what is the vehicle to do that between now and an approval, or can this just be 'addressed' as some post marketing approval follow up? Not sure how we weather another 6-12 months before the AOK.
|
|
|
Post by esstan2001 on Mar 28, 2014 10:49:55 GMT -5
liane- thank you.
pg 161 corroborates; the statistician has listed under 'other findings and issues'
There may be an issue on whether insulin aspart was optimally given in the control arm.
I think it will come down to how much weighting the other positive Pharmacokinetic and use factors demonstrated in the balance of the other trials will get..
T1DM.... tricky to call T2DM- I think this one happens.
(IMO)
|
|
|
Post by esstan2001 on Mar 28, 2014 9:27:52 GMT -5
regarding the FDA conclusions...
I think in the AdCom for T1DM there will be a lot of discussion on the data regarding GenII reducing A1C less than IA (insulin aspart- the comparator). I also (in my non expert opinion) do not believe this will b ea big enough issue to derail T1 approval; look at pg 173 Table 5: it is curious, but for men there is statistically no difference between GenII and IA. But there is a 0.4 improvement for women.
Go Figure.
T2DM data seems solid. T1DM data has this question. So what; label it for men only? So here is where it is important for all the other benefits of Afrezza to get weighed properly in the AdCom discussions (reduced excursions, faster acting & clearing, etc)
still reading
|
|
|
Post by esstan2001 on Mar 28, 2014 8:40:37 GMT -5
OK mdcenter, don't get too darn glad; I was reading the document prepared by Mannkind... no wonder it sounded so good.
Now on to the FDA version-
|
|
|
Post by esstan2001 on Mar 28, 2014 8:01:06 GMT -5
Even the way things are worded seems to assume this is moving forward toward an APPROVAL.
|
|
|
Post by esstan2001 on Mar 28, 2014 7:59:08 GMT -5
OK my intro- I've lurked at Proboards since day 1; great board.
After reading pp 147-155 (I figured the safety stuff and conclusions would make a good start) It looks like (not to get anyone's hopes too high but I was so exited I jumped through all the hoops to set up my account here this AM) the FDA is in love with Afrezza and this should be a slam dunk vote (unless nefarious BP moles are planted at the AdCom). I read and listened to the Arena & Unigene Docs & AdComs, and this briefing doc by far seems to be the most favorable to the drug. FDA appears to already have outlined an innocuous REMS that implements a communications plan to docs to monitor FEV in patients that are having more than the expected trouble with the mild cough, and a post marketing follow on study requirement for neoplasms; the only 2 things I find here... but KEY POINT: NO SAFETY SIGNALS FOUND for just about every concern ever brought up by the short side.
Matter of fact, this Briefing doc appears to debunk just about every technical 'concern' the shorts have ever brought up regarding Afrezza.
|
|